John D. Balian, MD

John D. Balian, MD

CEO International ClinChoice Inc; Board Director; Co-Founder

John D. Balian, MD, is the CEO International ClinChoice Inc; Board Director; Co-Founder. In February 2016, he founded the consulting firm MediVista, focusing on development of healthcare and IT companies and transformative technologies. Previously, he was a senior executive at Johnson & Johnson, where he served as Chief Medical Officer of the Johnson & Johnson Family of Consumer Companies, leading Medical, Clinical, Regulatory, Medical Safety, Toxicology, and related functions. In April 2014, Regional R&D was added to his remit and his title became Chief R&D Operations Officer.

Dr. Balian joined Johnson & Johnson from Pfizer Inc, where he was Senior Vice President, Worldwide Safety & Regulatory Operations. He led efforts to capitalize on the immense data streams Pfizer collects to gain new insights into patient needs and find new opportunities to serve them better. He launched and successfully executed a complete transformation of the organization’s structure, practices and strategies to address performance and regulatory challenges facing the company.

In 10 years at Pfizer, Dr. Balian held numerous leadership positions, originally joining as an Associate Director in Drug Safety before soon becoming Vice President and Global Head for Clinical Safety and Risk Management. In 2003, he was appointed VP in Development Operations, leading a multi-functional organization responsible for Pfizer’s sourcing strategies, capacity planning, clinical trials conduct and allocation, patient recruitment, performance measures and business/operational support for all clinical trials.

He also served at Bristol-Myers Squibb, leading the Global Pharmacovigilance & Epidemiology group and a Medical Affairs group focusing on mature brands. Among the many innovative methodologies he introduced was a BMS global operations center for pharmacovigilance in Chennai, India, an industry first.

Previously, Dr. Balian worked for the U.S. Food & Drug Administration, first as a Medical Reviewer for neuropharmacology products, and then as an Associate Director in the Office of Clinical Pharmacology and Biopharmaceutics. Widely published in scientific journals, he is also a published novelist. He earned his B.A. degree from Columbia University and his M.D. degree from Tufts University School of Medicine.

Oriana Zerbini

Oriana Zerbini

Founder, CEO of CROMSOURCE, a ClinChoice Company

Orian Zerbini, MD is the founder and CEO of CROMSOURCE, a ClinChoice company.  Dr. Zerbini worked for more than ten years at GSK where she contributed to the worldwide development of one of its blockbuster products, leading clinical research programs at national and international level.

On 15th July 1997 she founded CROM with Headquarters in Italy, and shortly afterwards expanded into Central and Eastern Europe, becoming one of the first CROs to be active in that region. Stability, integrity, high quality services and a high level of customer satisfaction contributed to the global development of the company across Europe and the United States. In fact, in April 2011, Dr. Zerbini acquired Msource (a medium-sized, European CRO with an established presence throughout Western Europe, both in clinical research and clinical resourcing/staffing). The company rebranded as CROMSOURCE, offering clients a truly comprehensive in-house service portfolio. Then in May 2012 she acquired Pleiad Inc to add further presence in the US and formally established the US headquarters.

On the technological side of the business, in 2009 she founded Techorizon, as a spin-off of the IT department of CROMSOURCE.

Dr. Zerbini also managed the development and operations of a European Phase I unit for nearly 10 years.

Oriana is very involved in the company working side by side with the business development and the operations teams offering her strong experience in the development of products for the life sciences industry. She is always available for her employees and clients alike. It is common practice for the clients to be able to reach out Oriana when they need to. She is truly passionate about the work that the Company does and enjoys taking a hands-on approach to helping clients with their projects.

Tiepu Liu, MD, PhD

Tiepu Liu, MD, PhD

President, Head of Biometrics

Tiepu Liu, MD, PhD, is President, Head of Biometrics at ClinChoice. He leads goal setting and strategic plans, and manages organizational structure and operational standards and process. He supports experienced clinical development teams specialized in data management, biostatistics and programming, and data science and technology to provide high quality and efficient services to global biopharmaceutical clients.

Dr. Liu served as a Biostatistician and Epidemiologist at the UAB Comprehensive Cancer Center and led a Biostatistics and Epidemiology group at the University of Cincinnati. In his industry career, he has served as Director of Biostatistics at PPD, Executive Director of Statistics and Data Management at UBC, and Senior Director of Biostatistics at Graceway Pharmaceuticals and The Medicines Company.

Dr. Liu has published over 100 scientific papers. He has worked with numerous Data Monitoring Committees (DMCs) in various capacities. Dr. Liu has led numerous clinical development programs in various therapeutic areas. He served as core lead in gaining global approval and successful commercialization of Arestin (minocycline), Zyclara (imiquimod), and Kengreal (cangrelor) interacting with various regulatory agencies, including FDA, EMA, PMDA, and NMPA.

Dr. Liu received his doctoral degree in Biostatistics and Epidemiology from the University of Alabama at Birmingham (UAB) after completing Medical and Public Health training at Tongji Medical University, China.

Kerry Dyson, MSc, PhD

Kerry Dyson, MSc, PhD

International Head, Clinical Operations

Dr. Dyson serves as International Head, Clinical Operations, leading the ClinChoice team committed to delivering exceptional clinical development services and flexible support to pharmaceutical, medical device and consumer health clients.

Kerry has over 25 years of experience in clinical research within the pharmaceutical and CRO sectors. During this time, he has worked at all levels and across operational and commercial functions within the industry. Within each role Dr. Dyson enjoyed key responsibilities for providing strategic input to the successful growth and development of the company. Most recently, Kerry served as Chief Operating Officer of CROMSOURCE, leading teams delivering clinical operations, biometrics, regulatory, medical and pharmacovigilance services.

Dr. Dyson holds a PhD in Applied Physiology from Leeds Metropolitan University and MSc in Kinesiology from McMaster University. He has authored numerous academic publications and written various articles on clinical research topics.

Jimish Shah, MS, MBA

Jimish Shah, MS, MBA

International Head, Medical Affairs, Regulatory and Safety

Jimish Shah, MS, MBA, is the International Head, Medical Affairs, Regulatory and Safety (MARS) at ClinChoice. He provides global leadership and strategic direction to a team of highly talented physicians, doctorates, and life-sciences graduates who are providing comprehensive support to clients for their pharmacovigilance, regulatory and medical affairs need.

Mr. Shah has over 20 years of experience in academia, consulting, and the life-sciences industry. Mr. Shah started his career in the life-sciences industry by working with Novartis as a Medical Writer. Later, Mr. Shah worked with several other biopharmaceutical companies and supported clinical submission for over a dozen products under oncology, cardiovascular, and immunology areas. Mr. Shah also designed tools for automating patient narrative compilation and planning for clinical documents authoring, and implemented process optimization that has resulted in significant cost efficiencies for the organizations.

Mr. Shah earned his BS in Biotechnology from S. P. University (India), M.S. in Clinical Research from Cranfield University (UK) and MBA from the Simon Business School, University of Rochester (USA).

Troy McCall, PhD

Troy McCall, PhD

International Head, Commercial

As the International Head of Commercial at ClinChoice, Dr. McCall is responsible for the global commercial success of the organization. He currently oversees the Global Sales, Marketing, Corporate Communications, and Proposals functions to drive business growth and market share.

Dr. McCall brings more than thirty years of experience in the pharmaceutical and CRO industries, having worked for more than a decade each in increasingly senior positions in specialty pharma and life science services companies. He has a proven track record of success in leading and growing start-up, small, and medium-sized organizations. He has been a managing partner and/or CEO at four companies.

Throughout his career, Dr. McCall has consistently been successful in building value through a disciplined business approach which includes, but is not limited to, cost rationalization and expense management resulting in industry-leading margins, hands-on and effective engagement with clients, FDA, and other stakeholders, active participation with the sales and marketing organizations to significantly improve top-line results, and top-grading talent at all levels. He has extensive experience with growing and transforming companies and developing successful, sustainable organizations.

Lei Lu, MS, MBA

Lei Lu, MS, MBA

International Head of Business Operations

Lei Lu, MS, MBA, is the International Head of Business Operations at ClinChoice Inc. She provides leadership for strategies and processes and oversees activities in business operations, including procurement, legal, human resources, and day-to-day administration.

Ms. Lu has over 28 years of combined experience in the biotechnology, pharmaceutical, and CRO industries. Prior to joining ClinChoice, she worked at Merck for 20 years in diverse areas ranging from quality to R&D to global business procurement. Her broad experience allows her to provide oversight of business operations and think strategically with her deep understanding of the technical and business aspects of the pharmaceutical industry.

Ms. Lu has an MBA in finance from Temple University, an MS in Organic Chemistry from Texas Women’s University, and a BS in Chemistry from Sichuan University in China.

Nadia Di Matteo, Esq.

Nadia Di Matteo, Esq.

International Head of Legal Affairs

Nadia Di Matteo is the International Head of Legal Affairs Department.

She is responsible for advising ClinChoice on all legal matters by selecting the most appropriate solutions for the company according to local and international laws collaborating with external legal counsels.

Together with her international team, and interacting with appropriate business, financial and other internal functions, Nadia manages the negotiation and finalization of contractual terms with customers and suppliers and supports the operational teams on any legal matters if necessary. She is also responsible for managing all legal aspects relating to the ClinChoice personnel, staffing services and freelancers.

Nadia Di Matteo brings twenty years of experience in the field of clinical research. She worked for almost five years in an Italian Investigational Site as head of legal affairs. Then in 2008 she started her career in CROMSOURCE, an international CRO, where she initially dealt with the negotiation and finalization of contracts with customers and suppliers and then, after about three years, she was promoted to Director of the Legal Affairs Department.

Nadia graduated in Law at the University of Teramo (Italy) and she is licensed as an Italian lawyer.

Simona Colazzo

Simona Colazzo

International Head of HR and ESG

Simona Colazzo is the International Head of HR and ESG.

She is responsible for developing and implementing the global HR strategy, driving HR initiatives, and ensuring alignment with business goals.

Together with the regional HR Teams, and interacting with the Senior Management, Simona, oversees the implementation and standardization of HR policies, processes, and programs across multiple countries and regions in compliance with local labour laws, regulations, and employment practices. She leads global HR projects specifically in the areas of succession planning, talent management, change management, organizational and performance management, compensation and benefits, training and development. She is also responsible for leading the development and implementation of ESG initiatives aligned with organizational values.

Simona was awarded a degree in Biological Science at the University of Parma.

She joined CROMSOURCE in 2002, starting her career in pharmacovigilance and then leading numerous national and international clinical trials in various therapeutic areas. She then focused on quality assurance management, leading the Compliance team and in 2011 she became HR Director and  Executive Director. In 2016 she was appointed Chief HR Officer of CROMSOURCE

Mahesh Mudnur

Mahesh Mudnur

International Head of APAC

A co-founder of iMEDGlobal (a ClinChoice Company), Mahesh has more than 27 years of industry experience including 14 years of designing and implementing global software solutions in the healthcare and pharmaceutical domains.

His most recent experience includes tenures as CEO iMEDGlobal Inc – a KPO company providing services in the life sciences space. He was instrumental in taking the company from inception to a 500+ member strong company. He was also the Global Head, Product Development at ArisGlobal, India, and Engineering Manager at WYSE, India. He has also worked as a consultant, with DSA to help develop its IT service offering for the life sciences industry and worked on the Triage XML Intake system. Prior to the Life Sciences space, Mahesh has worked extensively in the Banking and Enterprise domain designing and developing solutions.

Mahesh has a bachelor’s degree in Instrumentation Engineering from Bangalore University, India.

Somodipto Basu, MBA

Somodipto Basu, MBA

International Head of EMEA and IT

Somodipto Basu is the International Head of EMEA and Information Technology at ClinChoice. In this role, Somo heads up ClinChoice’s operations in the EMEA region and leads the Global IT and Technology Innovation practice. Somo is focused on bolstering ClinChoice’s deep life sciences expertise with the power of next-gen technologies to unlock new insights to improve compliance and efficiencies.

Since 2013, Somo has been responsible for client engagement and business management, expanding ClinChoice’s presence in Europe. As a technology evangelist, Somo has been at the forefront of developing lightweight and enterprise solutions for the life sciences domain.

Previously, Somo was part of the start-up leadership team at Synowledge LLC (now Qinesca), where he was instrumental in establishing the technology business unit and laying the foundation for its accelerated growth. Before Synowledge, Somo spent a decade with IBM managing key accounts mainly from the life sciences domain. Prior to IBM, he also served as a techno-functional business analyst at Pharmacia (a Pfizer company) and application developer at Reckitt & Colman.

Somo holds a BS degree and an Executive MBA from the Indian Institute of Management (IIM) Bangalore, India.

Lee King, MEd

Lee King, MEd

International Head of Business Development

Lee King is International Head of Business Development at ClinChoice Inc. Mr. King has more than 27 years of experience in clinical research encompassing all phases of development and commercialization in drugs, vaccines, and medical devices. Before joining ClinChoice, Mr. King was the Global Head of Business Development and Strategy at CPi Global CRO. He also served as the Global Head of Peri/Post Approval and Clinical Outcomes Assessments at ICON. Prior to ICON, Mr. King held various senior roles at PPD, both in Hematology/Oncology and Late Phase Development. His strong portfolio of business development and therapeutic experiences enables him to help sponsors with their strategic development planning, commercialization, and resource optimization.

Mr. King has a BA from The University of North Carolina at Wilmington, a master’s degree in education from East Carolina University, and a professional certificate in international business from University College Dublin.

Molly Sang, MBA, CPA

Molly Sang, MBA, CPA

International Head of Finance

Molly Sang is the International Head of Finance of ClinChoice Inc., where she brings over 20 years of extensive experience in audit, accounting, and financial management to the executive team.

As International Head of Finance, Molly oversees all facets of financial operations and management, including accounting, audit, treasury, and financial planning & analysis. Her journey with ClinChoice started in 2019, and since then, she has played a pivotal role in steering the financial course of the company, ensuring fiscal responsibility, and contributing to the overall success of the organization.

Prior to joining ClinChoice, Molly held key financial positions in multinational pharmaceutical, medical device, and CRO companies, where she successfully led financial teams and managed a broad range of financial responsibilities.

Molly is a Certified Public Accountant with a Master of Business Administration from the University of St. Thomas at Minneapolis, Minnesota, and a Bachelor of Arts from Peking University in China.

Valerie Perentesis, PharmD

Valerie Perentesis, PharmD

International Head of Medical Affairs

Valerie Perentesis, Pharm. D. is the International Head of Medical Affairs at ClinChoice Inc. Valerie is a seasoned leader with 25 years of experience in pharmaceutical & consumer R&D.

Valerie started her career in academia as an assistant professor at St John’s University. She then evolved to work as a clinical hospital pharmacist in the NYC area, where she held various positions leading up to Director of Pharmacy Services at Beth Israel Medical Center.

Later, Valerie advanced her career and moved into the pharmaceutical industry. She spent 25+ years in Research and Development at various companies, she started at Pfizer in the Regulatory/Pharmacovigilance Department holding various roles before moving into Portfolio Management at Pfizer where she managed one-third of Pfizer’s R&D portfolio. Before leaving Pfizer Valerie held the position of Compound Development Team Lead Infectious Diseases.

She then moved to BMS and held a variety of pharmacovigilance senior positions and was instrumental in outsourcing pharmacovigilance activities to India. She then moved on to JNJ-Janssen where she led their Global Pharmacovigilance Operations.

Lastly, prior to joining ClinChoice, Valerie headed up Global Pharmacovigilance Operations at Alexion.

She earned her Doctor of Pharmacy degree from the Medical University of South Carolina, her Bachelor’s Degree in Pharmacy from St. John’s University and an ASHP Accredited Residency from The University of California San Francisco.

Jayme Calhoun, MBA

Jayme Calhoun, MBA

International Head of Regulatory Affairs

Jayme Calhoun is the International Head of Regulatory Affairs for ClinChoice. In this role she oversees ClinChoice’s International Regulatory Centers of Excellence to deliver comprehensive regulatory support to clients. Jayme has over 25 years of industry experience spanning from Novel Drugs to Consumer products, with a focus on Medical Device regulations.

Prior to joining ClinChoice, Jayme was Vice President of Regulatory Affairs at a start-up biotechnology company where she created and grew a new regulatory department for initial applications and market expansion of devices, combination products, drugs, and consumer products. Prior to that, she was a Project Manager for a tissue based BLA project overseeing the timely completion of cGMP upgrades and Phase III clinical trials.

Earlier, Jayme spent 8 years with Surgical Specialties (this company is now called Corza Medical)  in Quality and Regulatory roles overseeing corporate regulatory and quality goals for 3 manufacturing facilities, and acting as a regulatory liaison for FDA, Notified Bodies, and PMDA audits. Her prior experience includes roles at Medtronic and GlaxoSmithKline. In addition to serving as a management representative for multiple Heath Authority audits, she has experience supporting international registrations, authoring FDA, Health Canada, and EU submissions, and is respected for her ability to work with regulators from both a quality and regulatory aspect.

Jayme received her Bachelor degree in Chemistry from Connecticut College and her Master of Business Administration degree from the University of Florida. Jayme holds a RAC certification in Medical Devices.

James Liu, MS

James Liu, MS

International Head of Quality and Strategy

James Liu, MS, is the International Head of Quality and Strategy at ClinChoice Inc. James is responsible for leading the activities related to the development and implementation of standard operating procedures (SOPs), policies and procedures that ensure quality standards are met throughout the Company. James builds strong relationships with key stakeholders globally ensuring alignment among management team members and legacy entities. James also leads the integration of key systems and processes and participates in strategic planning. James has experience with clinical operations, data management, programming, biostatistical analysis, safety management (pharmacovigilance), and regulatory affairs.

James has been working in the pharmaceutical and CRO industry since 2002. Prior to joining ClinChoice, he held a position at Wyeth/Pfizer as Manager, Analytical Information Systems and before that served as Compliance Specialist/Manager of Electronic Quality Systems at Mutual Pharmaceutical Company, Inc.

Mr. Liu earned his Master of Science degree in Electrical & Computer Engineering as well as Analytical Chemistry from the University of Wisconsin-Madison with his Bachelor of Science degree in Chemistry from Peking (Beijing) University, China.

Vanita Srinivasan, MD

Vanita Srinivasan, MD

International Head of Safety

Dr. Vanita Srinivasan is the International Head of Safety at ClinChoice. Dr. Srinivasan has over 18 years of healthcare experience supporting pharmaceutical, medical device, and consumer healthcare innovators. At ClinChoice, Dr. Srinivasan manages operations across all the delivery centers, leading teams for several large-, mid-, and small-sized clients. Under her leadership, we seamlessly deliver on-time, quality solutions for all our clients.

Dr. Vanita has helped pharmaceutical clients manage their clinical and post-marketing safety initiatives during her time in Accenture and IQVIA. She leverages her hands-on experience as a physician, medical writer, and Delivery Head for large case processing operations to give direction for ClinChoice’s growth. As a safety subject matter expert, Dr. Vanita designs solutions for pharmacovigilance and device safety and consults to set up global safety operations. Her expertise and leadership style has led to several collaborative engagements with our clients.

She holds a medical degree, is a post-graduate in Clinical Research from Cranfield University, and has an MBA from XLRI. She is a CQI IRCA certified ISO 9001:2015 Lead Auditor and trained on Implementation of MDR (BSI).

Why ClinChoice?

Behind our full suite of services is a team steeped in experience, expertise, and senior leadership engagement. ClinChoice guides development with agility and reliability, ensuring full compliance, gathering critical insights, and upholding the highest standards of delivery from pre- through post-approval. This commitment culminates in a partnership that drives meaningful positive change for patients and consumers.

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